Abstract | RATIONALE: OBJECTIVE: METHODS: Following a placebo lead-in, 120 participants were randomized to pregnenolone or placebo for 8 weeks (Institute for Mental Health, Singapore). Primary endpoints were changes in MATRICS Consensus Cognitive Battery (MCCB) composite scores ( cognitive symptoms), UCSD Performance-based Skills Assessment-Brief (UPSA-B) composite scores (functional capacity), and Scale for Assessment of Negative Symptoms (SANS) total scores (negative symptoms). A modified intent-to-treat analysis approach was utilized. RESULTS: No significant changes compared to placebo were demonstrated in composite MCCB scores. In contrast, participants randomized to pregnenolone (n = 56) demonstrated greater improvements in functional capacity (UPSA-B composite changes) compared to placebo (n = 55), p = 0.03. Pregnenolone was also superior to placebo in the communication subscale of the UPSA-B (p < 0.001). Serum pregnenolone changes post-treatment were correlated with UPSA-B composite score changes in females (r s = 0.497, p < 0.042, n = 17) but not in males. Mean total SANS scores were very low at baseline and did not improve further post-treatment. Pregnenolone was well-tolerated. CONCLUSIONS:
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Authors | Christine E Marx, Jimmy Lee, Mythily Subramaniam, Attilio Rapisarda, Dianne C T Bautista, Edwin Chan, Jason D Kilts, Robert W Buchanan, Eu Pui Wai, Swapna Verma, Kang Sim, Jayaraman Hariram, Rajesh Jacob, Richard S E Keefe, Siow Ann Chong |
Journal | Psychopharmacology
(Psychopharmacology (Berl))
Vol. 231
Issue 17
Pg. 3647-62
(Sep 2014)
ISSN: 1432-2072 [Electronic] Germany |
PMID | 25030803
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)
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Chemical References |
- Antipsychotic Agents
- Neurotransmitter Agents
- Pregnenolone
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Topics |
- Adult
- Antipsychotic Agents
(adverse effects, therapeutic use)
- Cognition
(drug effects)
- Diagnostic and Statistical Manual of Mental Disorders
- Double-Blind Method
- Female
- Humans
- Male
- Neurotransmitter Agents
(blood)
- Pregnenolone
(adverse effects, chemistry, therapeutic use)
- Psychiatric Status Rating Scales
- Schizophrenia
(drug therapy)
- Schizophrenic Psychology
- Sex Characteristics
- Treatment Outcome
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